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Clinical Data Management Group Leader: Becton Dickinson & Company (BD)

The Clinical Data Management Group Leader is responsible for the tactical execution of Clinical Data Management activities for Clinical Trials supported by BD Diagnostics - TriPath. Oversees data management and technical personnel in day-to-day activities while maintaining project schedules and high quality deliverables. Closely monitors resource allocation and work schedules, and provides input to performance reviews. Ensures adherence to quality system procedures, standards, and metrics. Sound data management judgment must be exercised within broadly defined regulations and internal procedures to achieve high quality and accurate clinical data.

Principal Accountabilities:

1. Leads and advises the group in design and execution of Clinical Data Management activities for Clinical Trials supported by BD Diagnostics - TriPath.
2. Reviews and approves work products to ensure consistency with standards and procedures.
3. Forecasts and monitors resource allocations.
4. Works with various businesses Clinical Operations functions for the execution of Clinical Trial activities.
5. Supervises and coaches Clinical Data Management and Technical associates.
6. Recommends and implements process improvement initiatives.
7. Demonstrates expertise in the use of commercially available Clinical Data Management Systems including Electronic Data Capture.
8. Provides guidance and expertise to Clinical Trials that are highly complex or novel to the group.
9. Ensures regulatory compliance for data management aspects of Clinical Trials.
10. Responsible for achievement of clinical project goals, project metrics, and agreed upon schedule.
11. Recruit, interview, and contribute to hiring decision for permanent, temporary, and contract staff.
12. Contributes to the development of department budgets and resource forecasting.
13. Performs data management tasks for Clinical Trials.
14. Provide necessary training to clinical associates.
15. Write reports and make oral presentations as required.
16. Normally receives no instruction on routine work, general instructions on new assignments.

Education and Experience Required:

• Bachelor's Degree required (computer science, life science, or related field)
• Minimum of 3-5 years experience in Clinical Data Management in Device Company or Contract Research Organization preferred. Pharmaceutical experience considered.
• 3 - 5 years experience in the following:
  • working in a regulated industry, GCP, ICH, and ISO.
  • device or drug development process.
  • developing and/or using Commercial Off the Shelf Clinical Data Management Systems
• 1-3 years supervisory, mentoring, or team leader experience.
• Must be computer literate with working knowledge of relational databases and office software packages such as Microsoft Office, Excel, PowerPoint, and Project.

Education and Experience Preferred:

• Graduate Degree in computer science, life science, or related field
• Knowledge of regulatory requirements, FDA, ICH, GCP etc. guidance
• Strong interpersonal skills, demonstrated capability of working on multiple projects at one time.
• Knowledge in relational databases and office software packages.
• Demonstrated ability to work within a matrix organization.
• Strong problem solving skills and attention to detail.
• Good time management skills
• Expertise in: Clinical Data Management Systems, Electronic Data Capture and knowledge of Clinical Trial Management System.
• Must be computer literate with working knowledge of relational databases and office software packages such as Microsoft Office, Excel, PowerPoint, and Project.

Supervisory Responsibility:

• Supervises a Clinical Data Management Specialist

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